FACT accreditation is a credential that has its greatest value in the peer-to-peer exchange of ideas to confirm and improve quality in patient care and laboratory services. Successful accreditation is awarded with two tangible items: an Accreditation Certificate and a final Accreditation Report. Although the certificate gets more prominence, often framed and mounted as a visual symbol of quality, the final report is a detailed accounting of what accredited programs implemented to reach compliance with all FACT Standards.
Each Accreditation Report provides important information related to an accredited program’s journey to initial or renewal accreditation. The final report includes:
- The name and location of the program
- The date of the on-site inspection
- The clinical, collection, processing, and/or banking sites and services associated with the accreditation
- Key personnel
- Identification of the FACT inspection team
- A description of the program
- Deficiencies and variances cited by the inspection team and approved by the Accreditation Committee
- Required responses to provide evidence of correction of each deficiency or acknowledgement of each variance
- The program’s responses documenting completion of corrective actions and compliance with Standards
- FACT’s response, or determination regarding the adequacy of the program’s corrective action
- Details of any additional follow up reports or documentation due to FACT
After completing the rigorous accreditation process, programs may debrief the contents of the Accreditation Report and then file it away, turning attention to its many other important duties until annual reporting is required. However, the final report is a valuable tool that can be used throughout the accreditation cycle.
Programs that have corrected deficiencies and submitted adequate evidence of correction and compliance with standards should be very proud of the work they have invested into improvement. Lessons learned throughout this process can be applied to the entire program. For example:
- How will we evaluate our corrective actions to confirm long-term effectiveness?
- What other strengths and weaknesses did we discover while correcting deficiencies?
- Are there further root cause analyses we should perform to prevent similar deficiencies?
- Can we apply the same process to evaluate other aspects of our program?
Ideas generated from this review of the Accreditation Report may be useful to maintaining the Quality Management program via audits, process development, personnel training, and other quality concepts.
External Confirmation of Quality
Apheresis collection facilities, cell processing facilities, and clinical services are each important in the context of blood and marrow transplantation, where accreditation covers the entire scope of the therapy from patient selection and treatment, through product selection, collection, processing, and administration. These same services participate in clinical trials often including products developed and manufactured by industry partners. These facilities recognize the importance of standards, have achieved voluntary FACT accreditation, and have played a major role in delivering new products to patients. They have used their quality programs and processes to quickly adapt to increasing numbers of products, procedures, and manufacturers. However, facilities have individually and collectively expressed concern regarding the growing number of on-site audits. The increased burden of preparing for, participating in, and responding to audits requires more resources to be diverted to these activities rather than toward patient care.
Commercial manufacturers who produce cellular therapy products for clinical trials or under an approved regulatory license may wish to leverage FACT accreditation to streamline audit activities, verify quality practices, and reduce the burden on health care entities. To do this, manufacturers may request a copy of the final FACT Accreditation Report. FACT does not provide Accreditation Reports to any entity except the accredited program. Accredited programs are not restricted from sharing these reports and may choose to provide them to manufacturers leveraging FACT accreditation, however, they are not required to do so.
Accredited programs or their hospital administration may be hesitant to disclose deficiencies cited during an on-site inspection. However, FACT accreditation is a voluntary, peer-based quality improvement process, during which some deficiencies can be expected at any program. The documented deficiencies demonstrate the rigor of the inspection process. The final report includes the description and documentation of the program’s corrective action, FACT’s determination of the adequacy of the response, and any additional follow up that may be indicated. Responses to deficiencies are an opportunity to proudly share a program’s process improvements. Programs should inquire of any commercial manufacturer regarding the confidentiality of information they provide to increase confidence in the use of the FACT report.
If a program chooses to provide the final Accreditation Report to a commercial manufacturer, it will likely be able to participate in an abbreviated site audit because the Accreditation Report can be used to confirm the quality systems in place meet FACT Standards. If a program chooses not to provide the report, it may be required to undergo a full site audit that will include requirements duplicative to the FACT Standards.